SAD,MAD and Food Effect Study of SAP-001 Tablets in Chinese Subjects

NCT06678581 | Completed Phase 1 FDA Drug

• 1 other identifier: SAP-001-103
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the pharmacokinetics (PK) profile of single or multiple oral doses of SAP-001 tablets in healthy Chinese subjects and gout patients with hyperuricemia. To evaluate the safety and tolerability of single oral doses of SAP-001 tablets in healthy Chinese subjects and multiple oral doses of SAP-001 tablets in gout patients with hyperuricemia. To evaluate the pharmacodynamics (PD) profile of single oral doses of SAP-001 tablets in healthy Chinese subjects and multiple oral doses of SAP-001 tablets in gout patients with hyperuricemia. To evaluate the pharmacokinetics profile of SAP-001 tablets in healthy Chinese subjects under fasted/fed conditions.

Conditions

Gout; Hyperuricemia

Outcome Measures

Primary Outcomes (7)

• maximum concentration (Cmax)

  PK parameters

  168 hours

• area under the drug concentration-time curve from time 0 to the last measurable concentration sample collection time t (AUC0-t)

  PK parameters

  168 hours

• area under the drug concentration-time curve from time 0 to 168 hours (AUC0-168h)

  PK parameters

  168 hours

• time to maximum concentration (Tmax)

  PK parameters

  168 hours

• elimination half-life (t1/2)

  PK parameters

  168 hours

• cumulative urinary excretion from 0 to 168 h (Ae0-168h)

  PK parameters

  168 hours

• cumulative urinary excretion rate, renal clearance (CLR168h)

  PK parameters

  168 hours

Secondary Outcomes (4)

• Serum uric acid area under curve (AUCUA)

  168 hours

• cumulative excretion of uric acid (AeUA)

  168 hours

• renal clearance (CLRUA)

  168 hours

• serum creatinine area under curve (AUCCr)

  168 hours

Study Arms (3)

SAP-001

EXPERIMENTAL

Four sequentially ascending dose cohorts are set in SAD study. Three sequentially ascending dose cohorts are set in MAD study.

Drug: SAP-001

Placebo

EXPERIMENTAL

placebo tablets for oral

Drug: Placebo

A Randomized, Open-label, two-period crossover FE study

EXPERIMENTAL

12 subjects are randomized in a 1:1 ratio to sequences A (fasting - fed) and B (fed - fasting).

Drug: SAP-001

Interventions

SAP-001 DRUG

Solid Oral Tablet

Also known as: SAP-001 tablet

A Randomized, Open-label, two-period crossover FE study; SAP-001

Placebo DRUG

Solid Oral Tablet

Also known as: placebo tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female Chinese subjects between the ages of 18 and 55 years (inclusive of the cutoff value, the time of signing the informed consent shall prevail) in good health (as determined by medical history, physical examination, 12-lead ECG \[heart rate \> 50 bpm, PR interval \< 200 ms, and QRS width \< 120 ms\], vital sign measurements, and normal or no clinically significant abnormalities in clinical laboratory evaluations as assessed by the investigator (or designee) at screening and Day -1);
• Body mass index between 18 and 28 kg/m2 (including the cutoff value) at screening, not less than 50 kg for men and 45 kg for women;
• Serum uric acid (sUA) level ≤ 420 μmol/L (7 mg/dL) during the screening period and no history of gout;
• Males and females of childbearing potential must agree to use at least one medically acceptable form of contraception (see Appendix for specific contraceptive measures) from screening through 3 months after the last dose;
• The subjects fully understand the purpose, nature, method and possible adverse reactions of the trial, voluntarily acts as a subject, and signs the informed consent form;
• Able to complete trial per protocol requirements.

You may not qualify if:

• Clinically abnormal diseases or factors, including but not limited to neurological, cardiovascular, hematological, hepatic, renal, gastrointestinal, respiratory, metabolic, endocrine, immunological, skeletal system diseases or other factors, which investigator considered inappropriate for study participation;
• Subjects with a history of gastrointestinal surgery or resection (subjects who have undergone appendectomy and/or herniorrhaphy may be included in the study);
• Clinically significant liver function test abnormalities define as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 1.5 times of the upper limit of normal (ULN) or total bilirubin (TBIL) \> ULN at screening or baseline (D-1); or history of clinically significant acute or chronic hepatitis (including infectious, metabolic, autoimmune, hereditary, ischemic, or other forms), liver cirrhosis, or liver tumor.
• Significant cardiovascular diseases, including:
• Acute decompensated heart failure, including exacerbation of chronic heart failure, manifests as signs and symptoms requiring hospitalization and/or intravenous diuretic therapy \[New York Heart Association (NYHA) class III to IV\], or hemodynamically significant valvular disease and/or other vascular obstructive lesions within 3 months prior to the screening visit;
• Any of the following within 6 months prior to the screening visit:
• Significant cardiac, cerebral, and/or carotid artery diseases, including but not limited to acute coronary syndrome, myocardial infarction, stroke, and/or transient ischemic attack, or unsatisfactory recovery or unstable control at screening;
• Major cardiovascular or percutaneous procedures, including cardiac ablation, coronary revascularization, and carotid angioplasty; cardiovascular disease likely to require surgical or percutaneous intervention during participation in the study or within 6 months of the screening visit;
• History of clinically significant cardiac arrhythmia, including but not limited to any of the following:
• Symptomatic bradycardia and/or symptomatic ventricular arrhythmia within 3 months prior to the screening visit;
• Second- or third-degree atrioventricular block, sick sinus syndrome, left bundle branch block;
• QTcF \> 450 ms for males and \> 470 ms for females prior to screening or randomization;
• History of QT prolongation, long QT syndrome, or torsade de pointes;
• Subjects with a history of malignancy (excluding basal cell carcinoma) within 5 years before screening;
• History of acute infection within 14 days prior to screening;

Sponsors & Collaborators

• Shanton Pharma Co., Ltd.: lead

Study Sites (1)

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Gout; Hyperuricemia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Li Li

  Shanton Pharma Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: November 7, 2024
• Study Start: May 29, 2023
• Primary Completion: December 20, 2023
• Study Completion: January 11, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)